510(k) K160467 ยท LZA Polymer Patient Examination Glove
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
| Applicant | Kossan International Sdn Bhd, Klang, MY |
| Decision | Substantially Equivalent, Aug 2, 2016 |
| Received | Feb 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160467
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.